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    Chemistry

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    Also known as: 1188-38-1, N-carbamyl-l-glutamic acid, (s)-2-ureidopentanedioic acid, Carbaglu, N-carbamylglutamate, N-carbamoyl-l-glutamic acid
    Molecular Formula
    C6H10N2O5
    Molecular Weight
    190.15  g/mol
    InChI Key
    LCQLHJZYVOQKHU-VKHMYHEASA-N
    FDA UNII
    5L0HB4V1EW
    Carglumic Acid
    Carglumic Acid is an orally active, synthetic structural analogue of N-acetylglutamate (NAG) and carbamoyl phosphate synthetase 1 (CPS 1) activator, with ammonia lowering activity. NAG, which is formed by the hepatic enzyme N-acetylglutamate synthase (NAGS), is an essential allosteric activator of the enzyme carbamoyl phosphate synthetase 1 (CPS 1). CPS 1 plays an essential role in the urea cycle and converts ammonia into urea. Upon oral administration, carglumic acid can replace NAG in NAGS deficient patients and activates CPS 1, which prevents hyperammonaemia.
    Carglumic acid is a Carbamoyl Phosphate Synthetase 1 Activator. The mechanism of action of carglumic acid is as a Carbamoyl Phosphate Synthetase 1 Activator.
    1 2D Structure

    Carglumic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-(carbamoylamino)pentanedioic acid
    2.1.2 InChI
    InChI=1S/C6H10N2O5/c7-6(13)8-3(5(11)12)1-2-4(9)10/h3H,1-2H2,(H,9,10)(H,11,12)(H3,7,8,13)/t3-/m0/s1
    2.1.3 InChI Key
    LCQLHJZYVOQKHU-VKHMYHEASA-N
    2.1.4 Canonical SMILES
    C(CC(=O)O)C(C(=O)O)NC(=O)N
    2.1.5 Isomeric SMILES
    C(CC(=O)O)[C@@H](C(=O)O)NC(=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    5L0HB4V1EW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Carbamylglutamate

    2. N-carbamoyl-l-glutamate

    3. N-carbamoylglutamate

    4. N-carbamylglutamate

    2.3.2 Depositor-Supplied Synonyms

    1. 1188-38-1

    2. N-carbamyl-l-glutamic Acid

    3. (s)-2-ureidopentanedioic Acid

    4. Carbaglu

    5. N-carbamylglutamate

    6. N-carbamoyl-l-glutamic Acid

    7. Ureidoglutaric Acid

    8. Carbamylglutamic Acid

    9. Carbamino-l-glutamic Acid

    10. (2s)-2-(carbamoylamino)pentanedioic Acid

    11. L-n-carbamoylglutamic Acid

    12. N-carbamyl-l-glutamate

    13. N-carbamyl-glutamic Acid

    14. L-glutamic Acid, N-(aminocarbonyl)-

    15. Oe-312

    16. 5l0hb4v1ew

    17. N-carbamoyl-l-glutamate

    18. Chebi:71028

    19. N-carbamoylglutamate

    20. Oe 312

    21. Nsc-760124

    22. Oe 312 (laboratory Code Designation)

    23. Dsstox_cid_26706

    24. Dsstox_rid_81839

    25. Dsstox_gsid_46706

    26. Carglumic Acid [inn]

    27. Carbamylglutamate

    28. Carbaglu (tn)

    29. Cas-1188-38-1

    30. N-(aminocarbonyl)-l-glutamic Acid(carglumic Acid)

    31. Unii-5l0hb4v1ew

    32. Carglumic Acid [usan:inn]

    33. Carglumic-acid

    34. Acido Carglumico

    35. Acide Carglumique

    36. Acidum Carglumicum

    37. Glutamic Acid, N-carbamoyl-, L-

    38. Ncgc00167549-01

    39. Carglumic Acid [mi]

    40. Carglumic Acid [jan]

    41. Carglumic Acid [usan]

    42. Schembl373546

    43. Carglumic Acid [vandf]

    44. Gtpl7458

    45. Carbamyl-l-glutamic Acid

    46. Carglumic Acid [mart.]

    47. Carglumic Acid [usp-rs]

    48. Carglumic Acid [who-dd]

    49. Chembl1201780

    50. Dtxsid7046706

    51. Carglumic Acid (jan/usan/inn)

    52. Carglumic Acid [ema Epar]

    53. Oe312

    54. Bcp16753

    55. Hy-b0711

    56. Zinc1530283

    57. Tox21_112544

    58. Carglumic Acid [orange Book]

    59. Mfcd00047874

    60. S5301

    61. Akos010384789

    62. N-carbamyl-l-glutamic Acid Crystalline

    63. Tox21_112544_1

    64. Cs-8208

    65. Db06775

    66. Nsc 760124

    67. Ncgc00274073-01

    68. Ds-17934

    69. C-1805

    70. C05829

    71. D07130

    72. A804117

    73. Q822884

    74. J-507608

    75. Z1551429737

    76. Carglumic Acid, United States Pharmacopeia (usp) Reference Standard

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 190.15 g/mol
    Molecular Formula C6H10N2O5
    XLogP3-2.4
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count5
    Exact Mass190.05897142 g/mol
    Monoisotopic Mass190.05897142 g/mol
    Topological Polar Surface Area130 Ų
    Heavy Atom Count13
    Formal Charge0
    Complexity227
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameCarbaglu
    PubMed HealthCarglumic acid (By mouth)
    Drug ClassesHyperammonemia Agent
    Active IngredientCarglumic acid
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanyOrphan Europe

    2 of 2  
    Drug NameCarbaglu
    PubMed HealthCarglumic acid (By mouth)
    Drug ClassesHyperammonemia Agent
    Active IngredientCarglumic acid
    Dosage FormTablet
    RouteOral
    Strength200mg
    Market StatusPrescription
    CompanyOrphan Europe

    4.2 Drug Indication

    For the treatment of acute and chronic hyperammonaemia in patients with N-acetylglutamate synthase (NAGS) deficiency. This enzyme is an important component of the urea cycle to prevent build up of neurotoxic ammonium in the blood.

    FDA Label

    Carbaglu is indicated in treatment of:

    - hyperammonaemia due to N-acetylglutamate-synthase primary deficiency;

    - hyperammonaemia due to isovaleric acidaemia;

    - hyperammonaemia due to methymalonic acidaemia;

    - hyperammonaemia due to propionic acidaemia.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    The median Tmax of Carbaglu was 3 hours (range: 2-4). The daily dose of carglumic acid ranges from 100 to 250 mg/kg and this does are normally adjusted to maintain normal plasma levels of ammonia.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    CARGLUMIC ACID
    5.2.2 FDA UNII
    5L0HB4V1EW
    5.2.3 Pharmacological Classes
    Carbamoyl Phosphate Synthetase 1 Activators [MoA]; Carbamoyl Phosphate Synthetase 1 Activator [EPC]
    5.3 ATC Code

    A16AA05

    A - Alimentary tract and metabolism

    A16 - Other alimentary tract and metabolism products

    A16A - Other alimentary tract and metabolism products

    A16AA - Amino acids and derivatives

    A16AA05 - Carglumic acid

    5.4 Absorption, Distribution and Excretion

    Absorption

    30% bioavailability; Cmax, mean, 100 mg/kg dose = 2.6 g/mL (range of 1.9 - 4.8) Carglumic acid is not subject to to intracellular degradation.

    Route of Elimination

    Following administration of a single radiolabeled oral dose of 100 mg/kg of body weight, 9% of the dose was excreted unchanged in the urine and up to 60% of the dose was excreted unchanged in the feces.

    Volume of Distribution

    The apparent volume of distribution was 2657 L (range: 1616-5797).

    Clearance

    The apparent total clearance was 5.7 L/min (range 3.0-9.7), the renal clearance was 290 mL/min (range 204-445), and the 24-hour urinary excretion was 4.5 % of the dose (range 3.5-7.5).

    5.5 Metabolism/Metabolites

    A proportion of carglumic acid may be metabolized by the intestinal bacterial flora. The likely end product of carglumic acid metabolism is carbon dioxide, eliminated through the lungs.

    5.6 Biological Half-Life

    Median values for the terminal half-life was 5.6 hours (range 4.3-9.5).

    5.7 Mechanism of Action

    Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG), which is an essential allosteric activator of the liver enzyme carbamoyl phosphate synthetase 1 (CPS1). CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. Carglumic acid acts as a replacement for NAG in NAGS deficiency patients by activating CPS1 but it does not help to regulate the urea cycle.

    API Reference Price

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    ABOUT THIS PAGE

    Looking for 1188-38-1 / Carglumic Acid API manufacturers, exporters & distributors?

    Carglumic Acid manufacturers, exporters & distributors 1

    23

    PharmaCompass offers a list of Carglumic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Carglumic Acid manufacturer or Carglumic Acid supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carglumic Acid manufacturer or Carglumic Acid supplier.

    PharmaCompass also assists you with knowing the Carglumic Acid API Price utilized in the formulation of products. Carglumic Acid API Price is not always fixed or binding as the Carglumic Acid Price is obtained through a variety of data sources. The Carglumic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Carglumic Acid

    Synonyms

    1188-38-1, N-carbamyl-l-glutamic acid, (s)-2-ureidopentanedioic acid, Carbaglu, N-carbamylglutamate, N-carbamoyl-l-glutamic acid

    Cas Number

    1188-38-1

    Unique Ingredient Identifier (UNII)

    5L0HB4V1EW

    About Carglumic Acid

    Carglumic Acid is an orally active, synthetic structural analogue of N-acetylglutamate (NAG) and carbamoyl phosphate synthetase 1 (CPS 1) activator, with ammonia lowering activity. NAG, which is formed by the hepatic enzyme N-acetylglutamate synthase (NAGS), is an essential allosteric activator of the enzyme carbamoyl phosphate synthetase 1 (CPS 1). CPS 1 plays an essential role in the urea cycle and converts ammonia into urea. Upon oral administration, carglumic acid can replace NAG in NAGS deficient patients and activates CPS 1, which prevents hyperammonaemia.

    Carglumic Acid Manufacturers

    A Carglumic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carglumic Acid, including repackagers and relabelers. The FDA regulates Carglumic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carglumic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Carglumic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Carglumic Acid Suppliers

    A Carglumic Acid supplier is an individual or a company that provides Carglumic Acid active pharmaceutical ingredient (API) or Carglumic Acid finished formulations upon request. The Carglumic Acid suppliers may include Carglumic Acid API manufacturers, exporters, distributors and traders.

    click here to find a list of Carglumic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Carglumic Acid USDMF

    A Carglumic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Carglumic Acid active pharmaceutical ingredient (API) in detail. Different forms of Carglumic Acid DMFs exist exist since differing nations have different regulations, such as Carglumic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Carglumic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Carglumic Acid USDMF includes data on Carglumic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carglumic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Carglumic Acid suppliers with USDMF on PharmaCompass.

    Carglumic Acid JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Carglumic Acid Drug Master File in Japan (Carglumic Acid JDMF) empowers Carglumic Acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Carglumic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Carglumic Acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Carglumic Acid suppliers with JDMF on PharmaCompass.

    Carglumic Acid WC

    A Carglumic Acid written confirmation (Carglumic Acid WC) is an official document issued by a regulatory agency to a Carglumic Acid manufacturer, verifying that the manufacturing facility of a Carglumic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Carglumic Acid APIs or Carglumic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Carglumic Acid WC (written confirmation) as part of the regulatory process.

    click here to find a list of Carglumic Acid suppliers with Written Confirmation (WC) on PharmaCompass.

    Carglumic Acid NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Carglumic Acid as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Carglumic Acid API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Carglumic Acid as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Carglumic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Carglumic Acid NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Carglumic Acid suppliers with NDC on PharmaCompass.

    Carglumic Acid GMP

    Carglumic Acid Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Carglumic Acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Carglumic Acid GMP manufacturer or Carglumic Acid GMP API supplier for your needs.

    Carglumic Acid CoA

    A Carglumic Acid CoA (Certificate of Analysis) is a formal document that attests to Carglumic Acid's compliance with Carglumic Acid specifications and serves as a tool for batch-level quality control.

    Carglumic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Carglumic Acid CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Carglumic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Carglumic Acid EP), Carglumic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carglumic Acid USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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